Parenteral fluid container and closure assembly therefor



Oct- 5, 1965 A. F. BLUM @imam 392%),7@

PARENTERAL FLL'IID CONTAINER AND CLOSURE ASSEMBLY THEBEFOR Filed June l1, 1962 2 Sheets-Sheet l afa-.1

Oct. 5, 1965 A. F. BUJAN ETAL 3,209,752

PARENTERAL FLUID CONTAINER AND CLOSURE ASSEMBLY THEREFOR Filed June l1, 1962 2 Sheets-Sheet 2 Fig 6 84 as az Inventors Albert I". Bajar-L George R. Rgan Douglas A. Loper' Mtorneg/ United States Patent O 3,209,752 PARENTERAL FLUID CONTAINER ANI) CLSURE ASSEMBLY THEREFR Albert F. Bujan and George R. Ryan, Waukegan, and Douglas A. Loper, Wiunetka, lill., assignors to Abbott Laboratories, North hicago, Ill., a corporation of Illinois Filed .lune 1l, 1962, Ser. No. 201,442 6 Claims. (Cl. 1128-272) This application is a continuation in part of application Serial No. 787,589, now abandoned.

The present invention relates generally to a protective closure assembly for tubular passage means and more particularly to improved protective closure assembly for venoclysis equipment.

The present invention in one of its preferred embodiments is applicable to equipment for the receiving, storing and dispensing of parenteral fluids, including whole blood, blood plasma, glucose solution and similar parenteral fluids. In equipment of the foregoing type in which whole blood is stored, for example, it is important that the stored blood be maintained in a sterile condition and be readily accessible from the container for administration. In many instances wherein flexible containers are used to store blood, difficulties are encountered in maintaining the point of entry opening thereinto sterile.

In order to administer the blood or other parenteral fluid from a flexible container, it is necessary to provide some passage means for entry of the cannula or the like into the interior of the storage container for conducting the blood therefrom through a length of tubing to the patient. It is also of prime importance that it be definitely known at the time of administration that the passage means has been exposed to possible contamination. Another important requirement is that the entry passage be provided with walls or other means which firmly engage the piercing cannula to provide a tight seal therewith and prevent leakage and contamination during administration.

Heretofore, the sterility of the tubular passage means of containers of the above type has been maintained by providing oppositely disposed flaps extending from the body of the container which sealably enclose the outer end of the passage means and which have pull tab elements extending beyond the sealed area thereof for exposing the end of the passage means immediately prior to administration of the uid. It is difficult, however, to provide the required seal between the flaps to maintain sterility and yet permit conveniently opening the seal without the pull tab elements tearing off before the seal is properly opened.

It is therefore an object of the present invention to provide an improved protective closure assembly for a tubular passage means adapted to conveying a fluid.

It is also an object of the present invention to provide a tubular passage means with improved tamper-indicating closure assembly which protects the passage means against contamination.

It is still a further object of the present invention to provide a iiuid container with an improved closure assembly of simple construction.

The foregoing objects and other advantages of the present invention will be readily appreciated by reference to the following detailed description when considered in conjunction with the accompanying drawing showing speific embodiments of the present invention wherein:

FIGURE 1 is a fragmentary side elevational view of a flexible container with the improved closure assembly of the present invention partially in vertical sectional View.

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FIGURE 2 is a fragmentary side elevational view of the container and closure asesmbly of FIGURE 1 in one stage of manufacture.

FIGURE 3 is a vertical sectional view along the line 3-3 in FIGURE l.

FIGURE 4 is a side elevational View of several modilied forms of the closure cap shown in FIGURES l and 2.

FIGURE 5 is a fragmentary side elevational View of a modified form of the protective closure assembly of the present invention partially in Vertical sectional view.

FIGURE 6 is a vertical sectional View partially in side elevation showing the present invention applied to a protective closure cap of a needle adapter and tubing assembly.

FIGURE 7 is a plan view of the assembly shown in FIGURE 6.

FIGURE 8 is a vertical sectional view along the line 8-8 of FIGURE 7.

FIGURE 9 is a plan view partially in vertical section showing the present invention applied to a protective closure cap for a hypodermic needle having a needle and hub assembly.

In the embodiment of the invention illustrated in FIG- URE 1 of the drawing, the flexible blood container body section It) is comprised preferably of two wall sheets or sections 1l, l2 of flexible, chemically inert and physically non-porous plastic material, preferably plasticized polyvinylchloride, which are joined by applying heat and pressure to form cross-weld seals I3, 13 at the lateral edges, a top edge seal I4 and a bottom edge seal 15. A supporting means 16 can be formed in the bottom edge of the body section 10. Disposed between wall sheets 11, I2 along the upper edge seal 14 is a tubular intake passage means 17 which has its innermost end integrally sealed between the wall sheets I1, l2 and communicating with the interior of the said body section 10. The passage means 17 has attached to the outer end thereof a needle hub 18, a collection needle 19, which is enclosed in a protective hood or closure cap 2li. Located within the end of the intake passage means 17, at a point where tube I7 is sealed to the body section I0 is a valve ball 21 sealably closing the end of the passage means 17.

Disposed along the upper edge seal 14 of the body section It) and preferably on opposite sides of the intake passage means I7 are tubular passage means 22 and 23 communicating with the interior of the container body. The tubular passage means 22, 23 are each sealably joined to the wall sheets 11, 12 and extend outwardly and inwardly from the top edge seal 14 of the body section Il).

The tubular passage means 22 and 23 are comprised preferably of a short length of plastic tubing 24, 24', respectively, which are preferably of the same material as the body section 10 each having pierceable diaphragms 25 and 25', respectively, positioned intermediate the ends thereof. The lower ends of passage means 22 and 23 are preferably split diametrically to provide a pair of oppositely disposed protective wall flaps 26 and 26', respectively.

Removably mounted on the outer end of each of the passage means 22, 23 is a protective 4closure cap 27, 27', respectively, having identical structure and each making a fluid impervious engagement with the passage means 22, 23, respectively The closure caps 27 27 are formed of relatively rigid plastic material which is not readily deformed by heat or pressure and which does not become sott and tacky under the degree of heat and pressure used to seal the walls 1l, 12 together with the tubing 24, 24', respectively. Suitable plastic material for the closure caps 27, 27' includes polyethylene, polypropylene, polyamides, and modified acrylics. The inner wall surface 28 of the cap means 27 is preferably tapered slightly inwardly so that the upper or closed end has a slightly smaller diameter than the open end thereof. Thus, when the cap means 27 is seated on the passage means 22, for example, the outer end of the passage means 22 is compressed inwardly. Thus, when the container is heat sterilized with the cap means 27 positioned on the passage means the end of the tubing 24 takes a permanent set so that the outer end has a smaller diameter than the remainder of the said tubing and lirmly grips a hub assembly when it is inserted therein.

Extending longitudinally from the lower edge of the body section 29, 29' of the closure caps 27, 27', respectively, are retaining and indicator tab elements 30, 30', respectively. When the closure caps are operatively mounted on the tubular passage means 22, 23, respectively, the tab elements 30, 30' are interposed between the outer surface of the wall of the passage means 22, 23, respectively, and the wall sheet 11. The tab elements 30, 30' are securely but releasably locked between the wall sheet 11 and the passage means 22, for example, until such time as the respective closure caps 27, 27' are removed from the passage means 22, 23, respectively.

The cap retaining and indicator tab elements 30, 30' are preferably in the form of two oppositely disposed arms 31, 31 with an enlarged end section in the form of a short section 32, 32' extending perpendicularly to each of the arms 31, 31', respectively and formed integrally therewith. If desired, however, the tab elements can be made in the form of an inverted V with outwardly tapered walls or with divergent arms 33, 33 (FIGURE 4) or in the form of a wedge 34 (FIGURE 4) or in any similar form in which the tab has its maximum width at a point spaced outwardly from the lower edge of the said closure cap and is adapted to provide frictional engagement with the contiguous parts and yet permit removal of the cap and tab element, preferably without rupture thereof. In one form of the invention, however, the tab elements 36 adjacent the point of juncture with the lower edge of the body section of the cap is provided with a rupturable portion 37 which is readily severable at the rupturable portion 37 so that the closure cap can be removed when desired. In each of the above cap structures it should be understood that it is within the scope of the present invention to use one or more tab elements on the cap member, although in the preferred embodiments two tab elements disposed on diametrically opposite sides of the cap are used.

In fabricating the flexible blood container with the improved protective closure means of the present invention, the closure cap 27, for example, is rst fully seated on the outer end of the plastic tubing 24, with the tab elements 30, 30 extending downwardly along the outer surface of the tubing. The tubing 24 with the closure cap 27 assembled thereon is then placed between the upper edges of the wall sheets 11, 12, prior to forming the upper edge seal 14 with the tab elements 31D, 30' being substantially covered by the wall sheets 11, 12 but without, however, covering the body section 29 of the cap. When the desired number of the said cap and tubing assemblies have been positioned between the wall sheets 11, 12, the required pressure and heat is applied to form a secure upper edge seal 14 which sealably secures the lower end of the tubing 24 between the sheets 11, 12 and releasably locks the tab elements 3@ between the tubing 24 and contiguous wall sheet 11 without, however, forming a plastic seal with the tab elements.

Immediately prior to withdrawing fluid from the container, the closure cap 2'7 is removed simply by grasping the body section 29 of the closure cap 27 and pulling outwardly to withdraw the tab element 30 from between the wall sheet 11 and the tubular passage means 22.

Once the closure cap 2'7 is removed from the tubular passage means 22, the reinsertion of the tab elements 30, 30' into their former position between the wall sheet 11 and the tubular passage means 22 is prevented by the short section 32, for example. Thus, the tab elements 30, 30' serve as a positive means of indicating when the cap means 27 has been removed from the tubular passage means 22 to expose the tubular passage means 22 to possible contamination.

A diaphragm piercing needle at the end of a length of tubing is then introduced into the end of the tubing 24 where it is securely held by the constriction dened by the reduced diameter end section 28 of the tubing, piercing the diaphragm 25, and premitting the huid in the container to pass outwardly through the tubing having an administration needle secured to the outer end thereof.

In an alternative embodiment of the invention shown in FIGURE 5 of the drawings, a tubular passage means 70 is provided with a sleeve 71 having the lower section thereof integrally secured to the tubular passage means adjacent the upper seal 14' and overlying the upper portions only of indicator tab elements '72 and itting over the lower end of a closure cap 73 without, however, being sealably joined thereto. In the latter embodiment lower ends 74 of each tab element 72 extend beyond the sleeve '71 and are releasably locked between the wall sheets 11 and 12 and the tubular passage means forming a part of the seal 14. The sleeve 71 provides the tamper-proof or tamper-indicating closure assembly with additional protection against accidental contamination by enclosing the lower edge of the closure cap 73.

As with the embodiment of the invention shown in FIGURES l through 4, the sleeve 71 and cap 73 are positioned on the tubular passage means '71) and then inserted between the wall sheets 11', 12' prior to forming the end seal 14 with the lower end of the sleeve 71 abutting the upper edge of the wall sheets 11', 12'.

As `shown in FIGURES 6 through 9 of the drawings, the present invention is also applicable to tubular passage means other than those associated directly with a iiuid container wall. Thus, it may be desirable to provide a tamper-proof or tamper-indicating closure assembly on a tubular member, such as the end of an administration tube having an adapter or a hypodermic needle mounted thereon. In the latter modilications the closure cap is provided with longitudinally extending indicator and retaining tab elements which are held firmly against the outer wall of the tubing by a sleeve which includes a pair of oppositely disposed small sections of scalable or joinable material, such as thermoplastic, polyvinylchloride or polyethylene plastic.

FIGURES 6 through 8 show a length of exible plastic tubing having means (not shown) for communicating with a source of a parenteral fluid and having a needle hub adapter 81 mounted on the end portion thereof. A closure cap 82 is mounted over the adapter 81 with the end of the cap 82 making an air impervious engagement therewith so that the enclosed parts do not become contaminated with air-borne bacteria or the like. The cap 82 is provided with at least one longitudinally extending indicator and retaining tab element 83. The retaining tab elements 83 overlie and are securely held against outwardly axial movement by means of a sleeve 84A which includes small oppositely disposed scalable sections 84, 84' of polyvinylchloride plastic or similar material which are sealably joined to each other and preferably to the plastic tubing 80 about the tab elements 83, thereby holding the tab elements 83 closely against the tubing 80 without, however, sealably engaging the tab elements 83. When it is desired to remove the cap 82, the operator merely grasps the body section S5 of the cap 82 and pulls outwardly to remove the tab elements 83 from their enclosure between the section 84 and the tubing 80. Since it is impossible to reinsert the tab elements between the scalable section 84, 84', respectively, and the tubing 80, there is clear evidence that the cap has been removed and that the adapter on the end of the tubing has possibly been exposed to contamination.

In FIGURE 9, the length of plastic tubing has a hypodermic needle 91 with hub assembly 92 mounted in the end portion thereof and a closure cap 93 fitted over the end of a cannula 91a and the hub assembly 92 and forming an air-tight engagement therewith. The cap 93 is provided with at least one indicator and retaining tab element 94, and preferably also with an oppositely disposed element 94', extending longitudinally from the lower edge thereof. The retaining and indicator tab elements 94, 94 are held securely against accidental outwardly axial movement by means of a short plastic sleeve 95 which is sealably joined to the tubing 90 or, if desired, to the hub assembly 92.

Others can readily adapt the invention for use under various conditions of service, by employing one or more of the novel features disclosed or equivalents thereof. Accordingly, the invention is not to be considered as limited save as is constant with the scope of the following claims.

What is claimed is:

1. In a plastic container having side wall sections and at least one tubular passage means communicating with the interior of the container sealably positioned between the said side wall sections thereof and extending outwardly therefrom, the improvement in a tubular passage means and closure thereof comprising; a length of plastic tubing sealably positioned between the side wall sections of a container in the upper edge seam thereof with one end of the said tubing communicating with the interior of the container and the outer end thereof extending outwardly beyond the said upper edge seam, a closure cap mounted on the outer end of the tubular passage means and forming an air-tight engagement thereabout; said cap having at least one tab element integral therewith extending longitudinally from the lower edge thereof disposed adjacent the outer wall of the said tubular passage means and extending between said passage means and at least one wall section in the said upper edge seam, and the said tab element being releasably locked against outward movement by being enclosed between said one side wall section and said tubular passage means which are in scalable engagement with each other about said tab element, said tab element being releasable from between said one of said side wall sections and said tubular passage means, said tab element having means for preventing said tab element from being relocked between said one of said side wall sections and said tubular passage means.

2. In a plastic container having side wall sections and at least one tubular passage means communicating with the interior of the container sealably positioned between the said side wall sections thereof and extending outwardly therefrom, the improvement in a tubular passage means and closure thereof comprising; a length of plastic tubing sealably positioned between the side wall sections of a container in the upper edge seam thereof with one end of the said tubing communicating with the interior of the container and the outer end thereof extending outwardly beyond the said upper edge seam, a closure cap mounted on the outer end of the tubular passage means and forming an air-tight engagement thereabout, said cap having at least one tab element integral therewith extending longitudinally from the lower edge thereof disposed adjacent the outer wall of the said tubular passage means and extending between said passage means and at least one wall section in the said upper edge seam, and the said tab element being releasably locked against outward movement by being enclosed between said one side wall section and said tubular passage means which are in scalable engagement with each other about said tab element, said tab element being releasable from between said one of said side wall sections and said tubular passage means, said tab element having a maximum width at a place spaced from the lower edge of said closure cap.

3. In a plastic container having side wall sections and at least one tubular passage means communicating with the interior of the container sealably positioned between 6 the said side wall sections thereof and extending outwardly therefrom, the improvement in a tubular passage means and closure thereof comprising; a length of plastic tubing sealably positioned between the side wall sections of a container in the upper edge seam thereof with one end of the said tubing communicating with the interior of the container and the outer end thereof extending outwardly beyond the said upper edge seam, a closure cap mounted 'on the outer end of the tubular passage means and forming an air-tight engagement thereabout, said cap having at least one tab element integral. therewith extending longitudinally from the lower edge thereof disposed adjacent the outer wall of the said tubular passage means and extending between said passage means and at least one wall section in the said upper edge seam, a first portion of said tab element being permanently locked against outward movement by being enclosed between one of said side wall sections and said tubular passage means which are sealably engaged about said tab element, a second portion of said tab element having a rupturable portion, said tab element at said rupturable portion being ruptured when a pulling force is applied to said cap and said rst portion remaining locked between said one side wall section and said tubular passage means.

4. In a plastic container having side wall sections and at least one tubular passage means communicating with the interior of the container sealably positioned between the said side wall -sections thereof and extending outwardly therefrom, the improvement in a tubular passage means and closure thereof comprising; a length of plastic tubing sealably positioned between the side wall sections of a container in the upper edge seam thereof with one end of the said tubing communicating with the interior of the container and the outer end thereof extending outwardly beyond the said upper edge seam, a closure cap mounted on the outer end of the tubular passage means and forming an air-tight engagement thereabout, said cap having at least one tab element integral therewith extending longitudinally from the lower edge thereof disposed adjacent the outer wall of the said tubular passage means and extending between said passage means and at least one wall section in the said upper edge seam, and the said tab element being releasably locked against outward movement by being enclosed between said one side wall section and said tubular passage means which are in scalable engagement with each other about said tab element, said tab element being releasable from between said one of said side wall sections and said tubular passage means, said tab element having means for preventing said tab elements from being relocked between said one of said side wall sections and said tubular passage means, and a sleeve secured to said passage means and overlying said tab element and a portion of said cap.

5. A closure assembly comprising: a tubular passage means having a closure cap enclosing the outer end of the said tubular passage means, said cap having at least one tab element extending longitudinally from the lower edge thereof and formed integrally therewith, said tab element being held against outwardly axial movement by a section of scalable material sealably joined to said tubular passage means about said tab element to maintain the said element in frictional engagement with said tubular passage means, the upper portion of said closure cap being substantially non-deformable and having the interior thereof tapered to provide the upper interior end thereof with a diameter which is smaller than the outer diameter of the end of said tubular passage means on which it is mounted, whereby said cap compresses the end of the tubular passage means causing the end of the tubing to become constricted.

6. A closure assembly comprising: a tubular passage means having a closure cap mounted on the outer end thereof, said cap having at least one tab element extending longitudinally from the lower edge of said cap and integral therewith, a section of scalable plastic material enclosing said tab element between said section and the contiguous portion of said tubular passage means, said cap being sealably joined to said tubular passage means about said tab element, the upper portion of said closure cap being substantially non-deformable and having the interior thereof tapered to provide the upper interior end thereof with a diameter which is smaller than the outer diameter of the end of said tubular passage means on which it is mounted, whereby said cap compresses the end of the tubing causing the end of the tubular passage 10 References Cited by the Examiner UNITED STATES PATENTS 2,079,757 5/37 Berk 215-7 2,687,831 8/54 Miller. 2,894,510 7/59 Bellamy 12S-272 2,997,043 8/61 Flynn 128-214 FOREIGN PATENTS 557,090 2/57 Italy.

RICHARD A. GAUDET, Primary Examiner.

JORDAN FRANKLIN, Examiner. 

1. IN A PLASTIC CONTAINER HAVING SIDE WALL SECTIONS AND AT LEAST ONE TUBULAR PASSAGE MEANS COMMUNICATING WITH THE INTERIOR OF THE CONTAINER SEALABLY POSITIONED BETWEEN THE SAID SIDE WALL SECTIONS THEREOF AND EXTENDING OUTWARDLY THEREFROM, THE IMPROVEMENT IN A TUBULAR PASSAGE MEANS AND CLOSURE THEREOF COMPRISING; A LENGTH OF PLASTIC TUBING SEALABLY POSITIONED BETWEEN THE SIDE WALL SECTIONS OF A CONTAINER IN THE UPPER EDGE SEAM THEREOF WITH ONE END OF THE SAID TUBING COMMUNICATING WITH THE INTERIOR OF THE CONTAINER AND THE OUTER END THEREOF EXTENDING OUTWARDLY BEYOND THE SAID UPPER EDGE SEAM, A CLOSURE CAP MOUNTED ON THE OUTER END OF THE TUBULAR PASSAGE MEANS AND FORMING AN AIR-TIGHT ENGAGEMENT THEREABOUT; SAID CAP HAVING AT LEAST ONE TAB ELEMENT INTEGRAL THEREWITH EXTENDING LONGITUDINALLY FROM THE LOWER EDGE THEREOF DISPOSED ADJACENT THE OUTER WALL OF THE SAID TUBULAR PASSAGE MEANS AND EXTENDING BETWEEN SAID PASSAGE MEANS AND AT LEAST ONE WALL SECTION IN THE SAID UPPER EDGE SEAM, AND THE SAID TAB ELEMENT BEING RELEASABLY LOCKED AGAINST OUTWARD MOVEMENT BY BEING ENCLOSED BETWEEN SAID ONE SIDE WALL SECTION AND SAID TUBULAR PASSAGE MEANS WHICH ARE IN SEALABLE ENGAGEMENT WITH EACH OTHER ABOUT SAID TAB ELEMENT, SAID TAB ELEMENT BEING RELEASABLE FROM BETWEEN SAID ONE OF SAID SIDE WALL SECTIONS AND SAID TUBULAR PASSAGE MEANS, SAID TAB ELEMENT HAVNG MEANS FOR PREVENTING SAID TAB ELEMENT FROM BEING RELOCKED BETWEEN SAID ONE OF SAID SIDE WALL SECTIONS AND SAID TUBULAR PASSAGE MEANS. 